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BAYER SUBMITS VARDENAFIL NDA FOR ERECTILE FUNCTION.

Bayer Corporation has submitted a New Drug Application (NDA) for vardenafil, an investigational compound for the improvement of erectile function, to the U.S. Food and Drug Administration (FDA).

Simultaneously, Bayer submitted vardenafil for regulatory review in Mexico.

"Current estimates suggest more than half of all men over the age of 40 experience some level of erectile dysfunction," said Irwin Goldstein, M.D., professor of urology at Boston University School of Medicine and a vardenafil investigator. "Erectile dysfunction is a complex medical condition for which physicians and patients are in need of new treatment options."

Erectile dysfunction (ED) -- the inability to sustain an erection sufficient for sexual intercourse -- is a medical condition that affects an estimated 30 million men in the U.S., but research shows only an estimated 11 percent are being treated. There are a number of causes for ED, including diabetes, cardiovascular disease, and medications such as antidepressants.

"The vardenafil NDA submission includes data from a variety of patient populations ranging from mild to the more difficult-to-treat patients, such as those with diabetes," said David R. Ebsworth, Ph.D., president and general manager, Business Group Pharma, Bayer AG. "This milestone represents an impressive 47-month development period from the beginning of preclinical testing to NDA submission. Pending FDA approval, Bayer hopes to launch vardenafil in the second half of 2002."

Bayer Commitment to Men's Health

Bayer Corporation's research and development in the field of erectile dysfunction strengthens the company's foundation in urology. Bayer Corporation is already established in men's health with Cipro(R)(a) (ciprofloxacin HCI) to treat chronic bacterial prostatitis due to E. coli and P mirabilis. Bayer also is marketing Viadur(TM)(b), the first and only, once-yearly, continuous testosterone suppression therapy to treat symptoms of advanced prostate cancer. Other men's health products include One-A-Day(R) Men's High Potency Multivitamin/Multimineral Supplement, One-A-Day(R) Prostate Health, and Bayer Immuno 1(TM) System Complexed Prostate Specific Antigen (cPSA) -- an assay used to measure prostate-specific antigen levels.

Best known for its flagship product, Bayer Aspirin, Bayer Corporation produces a broad range of health care, life science, and chemical products that help diagnose and treat diseases, purify water, preserve local landmarks, protect crops, advance automobile safety and durability, and improve people's lives.

Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion in 2000, and is one of Fortune magazine's Most Admired Companies. The company employs approximately 23,000 people. It is a member of the worldwide Bayer Group, a $29 billion international health care and chemicals group based in Leverkusen, Germany. The Bayer Group (BAYG.DE) stock is a component of the DAX, and is listed on multiple foreign exchanges.

For more information, 203/812-2624.
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Publication:Worldwide Biotech
Date:Nov 1, 2001
Words:448
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